Harpagophytum
Harpagophytum Procumbens Root
Boiron
Human Otc Drug
NDC 0220-2374Harpagophytum also known as Harpagophytum Procumbens Root is a human otc drug labeled by 'Boiron'. National Drug Code (NDC) number for Harpagophytum is 0220-2374. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Harpagophytum drug includes Harpagophytum Procumbens Root - 6 [hp_C]/6[hp_C] . The currest status of Harpagophytum drug is Active.
Drug Information:
| Drug NDC: | 0220-2374 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Harpagophytum |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Harpagophytum Procumbens Root |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Boiron |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pellet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HARPAGOPHYTUM PROCUMBENS ROOT - 6 [hp_C]/6[hp_C]
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Boiron
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 1OYM338E89
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0220-2374-41 | 6 [hp_C] in 1 TUBE (0220-2374-41) | 22 Jan, 2021 | N/A | No |
| 0220-2374-43 | 3 TUBE in 1 BOX (0220-2374-43) / 6 [hp_C] in 1 TUBE | 22 Mar, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose* harpagophytum 6c hpus (0.44 mg) ... relieves minor aches and pain associated with arthritis
Product Elements:
Harpagophytum harpagophytum procumbens root sucrose harpagophytum procumbens root harpagophytum procumbens root lactose, unspecified form
Indications and Usage:
Uses* tube - minor aches and pains associated with arthritis* box - temporarily relieves discomfort, stiffness, and minor pain due to arthritis
Warnings:
Dosage and Administration:
Directions tube - adults and children: at the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. box - adults and children 12 years of age and older: at the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved, or as directed by a doctor. if pain increases, take every 2 hours, up to 8 times a day. children under 12 years of age: ask a doctor
Stop Use:
Tube - stop use and ask a doctor if symptoms persist for more than 3 days or worsen box - stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. these could be signs of a serious condition.
Package Label Principal Display Panel:
Label label
Further Questions:
1-800-boiron-1 (1-800-264-7661), boironusa.com info@boiron.com made in france distributed by boiron, inc. newtown square, pa 19073